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Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients

13. juni 2019 oppdatert av: Silke Lange, Universität Duisburg-Essen

Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)

Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyskland
      • Essen, Tyskland, 45136
        • Department of Senology, Kliniken Essen-Mitte

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion criteria:

  • clinically proven breast cancer with an indication for breast conserving surgery with max. 50% volume reduction
  • physical and psychological ability to take part in relaxation training

Exclusion criteria:

  • serious psychiatric disorder
  • to time span to surgery shorter than 2 weeks or longer than 20 weeks

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: relaxation training
Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.
Atferdsmessig: relaxation training
The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.
Eksperimentell: acupuncture
Each participant of the experimental group 2 receives 3 acupuncture treatments with a semi-standardized acupoint scheme: once a week over 2 weeks and the day before surgery.
Annen: acupuncture
The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.
Eksperimentell: relaxation training and acupuncture
Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery.
Atferdsmessig: relaxation training
The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.
Annen: acupuncture
The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.
Ingen inngripen: usual care
Patients receive usual senological treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
presurgical psychological distress
Tidsramme: expected average of 13 days
Measured by 100mm visual analog scale 1 day pre surgery
expected average of 13 days
postsurgical pain
Tidsramme: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
expected average of 15 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
postsurgical psychological distress
Tidsramme: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
expected average of 15 days
postsurgical psychological distress
Tidsramme: expected average of 21 days
Measured by 100mm visual analog scale 1 week post surgery
expected average of 21 days
postsurgical pain
Tidsramme: expected average of 21 days
Measured by 100mm visual analog scale 1 week post surgery
expected average of 21 days
postsurgical nausea
Tidsramme: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
expected average of 15 days
postsurgical nausea
Tidsramme: expected average of 21 days
Measured by 100mm visual analog scale 1 week post surgery
expected average of 21 days
postsurgical fatigue
Tidsramme: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
expected average of 15 days
postsurgical fatigue
Tidsramme: expected average of 21 days
Measured by 100mm visual analog scale 1 week post surgery
expected average of 21 days
intraoperative analgesia use
Tidsramme: expected average of 14 days
intraoperative analgesia use is taken from operative logs
expected average of 14 days
intraoperative anesthesia use
Tidsramme: expected average of 14 days
intraoperative anesthesia use is taken from operative logs
expected average of 14 days
postoperative analgesia use
Tidsramme: expected average of 15 days
postoperative analgesia use is taken from medical records
expected average of 15 days
immunemodulation
Tidsramme: expected average of 14 days
natural killer cell activity is measured at begin of surgery
expected average of 14 days
immunemodulation
Tidsramme: expected average of 14 days
natural killer cell activity is measured at end of surgery
expected average of 14 days
Number of patients with adverse events
Tidsramme: expected average of 21 days
Number of patients with adverse events are measured one week post surgery
expected average of 21 days
presurgical psychological distress
Tidsramme: expected average of 13 days
Measured by Profile of Mood States (POMS) 1 day pre surgery
expected average of 13 days
postsurgical psychological distress
Tidsramme: expected average of 15 days
Measured by Profile of Mood States (POMS) 1 day post surgery
expected average of 15 days
postsurgical psychological distress
Tidsramme: expected average of 21 days
Measured by Profile of Mood States (POMS) 1 week post surgery
expected average of 21 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universität Duisburg-Essen

Etterforskere

  • Studiestol: Gustav J. Dobos, Prof, Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2014

Primær fullføring (Faktiske)

1. november 2018

Studiet fullført (Faktiske)

1. november 2018

Datoer for studieregistrering

Først innsendt

21. oktober 2014

Først innsendt som oppfylte QC-kriteriene

27. oktober 2014

Først lagt ut (Anslag)

28. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juni 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14-5778-BO

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